Opportunity

The regenerative medicine market – which utilizes regenerative cells, along with the body’s own reparative capabilities, to provide potential cures for illnesses, diseases, and injuries – is large and growing.

In the U.S. alone, the regenerative medicine market is estimated at $119 million for 2009, and is anticipated to grow to $8.2 billion by 2018. (Source: 2009 Stem Cell Summit)

Several trends – including aging baby boomers, rising expectations for medical cures, and increasing costs for existing healthcare treatments – have created a large potential market for breakthrough medical solutions led by regenerative medicine products.

In response to these and other issues, regenerative medicine offers an effective and cost-efficient method for delivering quality medical solutions to an array of health and medical problems, both now and well into the future.

Cardiac Treatment
Numerous efforts are underway focusing on the discovery, development and commercialization of cell therapies for the treatment of chronic and acute heart damage. The market opportunity includes: the eight million-plus Americans who have suffered from a heart attack, the five million Americans who have experienced heart failure, and the nearly 800,000 Americans who have a new heart attack each year. The cardiac
market is expected to exceed $429 million by 2014. (Source: 2009 Stem Cell Summit)

Vascular
Regenerative medicine holds great promise for the field of vascular medicine. Currently, vascular-related disease procedures performed in the U.S. total approximately 200,000 each year. Between eight to 12 million Americans suffer from vascular leg pain annually.

Orthopedics
Regenerative medicine has the potential to become a leading technology in the orthopedics field, specifically by using the patient’s own adipose-derived stem cells to aid in the recovery of damaged cartilage, bone and muscle. Orthopedic stem cell therapy, which eliminates much of the pain and complexity of traditional methods, has been used to help 29,000 patients. The orthopedic market for stem cell therapy in the U.S. is forecasted to grow to $560 million by 2014. (Source: 2009 Stem Cell Summit)

Aesthetics and Reconstructive Surgery
Tremendous regenerative medicine opportunities exist in the multi-billion dollar aesthetics market, which is expected to reach $8.9 billion by 2012. (Source: Medical Insight, Inc. May 2008) Opportunities exist in both reconstruction, such as with breast cancer patients after a mastectomy, as well as with general aesthetic opportunities, including dermal fillers and breast augmentation, among others.


Tissue Genesis Cell Isolation System

Tissue Genesis has developed the Tissue Genesis Cell Isolation System, which takes advantage of an easily accessible source of regenerative cells: adipose or fat tissue.  The CE-marked Tissue Genesis Cell Isolation System is a fully automated and easy-to-use system, which processes liposuctioned fat tissue and delivers isolated regenerative cells in about an hour.

The compact desktop unit requires no tissue pre-processing, and fits easily into any clinical environment.  The adipose-derived regenerative cells isolated by the Tissue Genesis Cell Isolation Systemprocess are ready for use in a variety of therapeutic applications under development by Tissue Genesis, its licensees, and a multitude of potential licensees within the marketplace.

The Cell Isolation System has been developed over the course of many years, with thousands of hours of research and engineering, millions of dollars in development costs, and a dedicated team who has taken the product from concept to reality in the operating room.  The instrument allows for point-of-care recovery of an average of 50 to 60 million regenerative cells per 60cc of a patient’s processed fat.  These cells can then be used at the site of injury or disease to amplify the body’s own repair process.  These cells are being used to accelerate healing, repair damaged and diseased tissue, and prevent scarring and loss of function.  The technology has moved from concept to reality with utilization in the operating room in an IRB approved human clinical spinal fusion study.

   
Tissue Genesis Cell Isolation System for derivation of cells for delivery in syringe
Cell Isolation System Brochure

Tissue Genesis Vascular Graft

The Tissue Genesis Graft, comprised of an expanded PolyTetraFluoroEthylene (ePTFE) graft, coated with a patient’s own adipose-derived cells, will provide an optimal solution for vascular implant grafts for peripheral vascular, cardiovascular, and renal dialysis patients.  The Tissue Genesis cell coated graft is targeted to offer a superior alternative to currently used methods in peripheral artery bypass graft procedures, saphenous veins used in Coronary Artery Bypass Graft (CABG) procedures, and arteriovenous fistulae in the renal dialysis market.

Using the Tissue Genesis Cell Isolation System and Tissue Genesis’ proprietary cell sodding technology, a patient’s own therapeutic cells will be extracted and used to create a cell-lined vessel for surgical implantation in a little over an hour.  The Tissue Genesis graft is expected to offer improved functional longevity and a more cost effective solution in these markets.